About the role

Senior Scientist overseeing aggregate safety reporting, risk management, and pharmacovigilance for ClinChoice, a global clinical research organization. Leading safety analyses, regulatory deliverables, and cross-functional stakeholder coordination.

Responsibilities

Deliver scheduled and ad hoc aggregate safety reports and act as report owner for assigned medium-to-large volume, standard-complexity reports
Maintain in-depth product knowledge and support Safety Management Team deliverables
Plan activities, conduct meetings, search databases, perform aggregate safety analysis and case-level review, write documents, and coordinate strategic safety projects
Collaborate with Therapeutic Area Safety Head, Medical Safety Officers, Safety Surveillance Physician, vendors, and other stakeholders on safety strategy
Ensure timely, high-quality safety reports and analyses
Initiate, conduct, and oversee internal and external database searches
Author, contribute to, and coordinate core safety deliverables
Ensure Pharmacovigilance Agreements and assessment-report commitments are met
Provide Safety Management Team support and lead assigned meetings
Guide risk management plan creation and updates
Lead or support PBRER/PSUR, health-authority query, signal evaluation, DSUR, labeling, literature-review, Product Safety Strategy, and escalation activities
Participate in cross-functional training, departmental meetings, Clinical Development Teams, Local Working Groups, and other initiatives
Recognize and escalate potential safety issues and address regulatory assessor comments and requests

Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent
Advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent (preferred)
Physician (MD or equivalent) generally requires 2–5 years of pharmacovigilance or other relevant experience
At least 3 years of clinical practice experience for physicians (preferred)
Clinical/medical writing or pharmacovigilance experience (preferred)
Strong English verbal and written communication skills
Knowledge of drug development principles, assessment of drug risks and benefits, safety assessment of marketed and in-development drugs, and global safety regulations (highly preferred)

Professional development and continuous training
Work-life balance
Quality-focused, collaborative “one-team” culture
Equal opportunity and inclusive, barrier-free recruitment and selection processes
Accommodation for qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act